Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417541
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-11
Brief Title:
Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters
Sponsor:
Thomas Kander
Organization:
Region Skane
Study Overview
Official Title:
Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters PHOTO CAT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHOTO CAT
Brief Summary:
Central venous CVC is essential in modern healthcare but unfortunately associated with complications including thrombosis In a recently published study it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis Rockholt et al To shed light on this problem the current studies were designed In sub-study 1 deceased patients with CVC who are referred for clinical autopsy are included Before the autopsy the deceased will be examined with a photon-counting computed tomography CT scan and the results will be compared
In sub-study 2 living patients with CVC who are referred for various CT scans without contrast are included After informed consent the patient will be examined with the photon-counting CT whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported
In sub-study 2 living patients with CVC who are referred for various CT scans without contrast are included After informed consent the patient will be examined with the photon-counting CT whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported
Detailed Description:
Purpose and specific objective The aim of the current project PHOTO CAT is to evaluate the prevalence of subclinical thromboses related to central venous catheters CVCs using a novel high-resolution photon-counting computed tomography CT scan and to evaluate the performance of the photon-counting CT compared to clinical autopsy
Scientific questions
1 Can the photon-counting CT diagnose subclinical CVK-related thromboses detected at later autopsy
2 How common are CVC-related thromboses in autopsies of deceased people with existing CVC
3 How does the performance of the photon counting DT compare to clinical autopsy
4 How common are CVC-related thromboses in a cohort that does photon-counting DT for various reasons and has a CVC
5 Can imaging be improved by adjustments to the DT protocol
6 Can an ultrasound scan on living patients diagnose subclinical CVK-related thrombosis detected by photon-counting CT
Background CVCs are essential in modern healthcare and have a wide range of applications They enable direct access to the central bloodstream and are used among other things to administer medicines nutrition and to monitor blood circulation Unfortunately they are associated with a variety of complications including thrombosis Studies report thrombosis incidences between 5 - 30 in living patients When the CVC is introduced into the blood vessel a number of physiological defense systems are initiated Inflammation and clotting are activated leading to the formation of a fibrin stocking around the catheter This can then develop into a catheter-related thrombosis which in turn can have serious consequences for the patient such as pulmonary embolism or infection
Photon-counting DT is the new generation of DT What distinguishes this from the traditional one is that the radiation through the body is detected with a new type of detector that measures each X-ray which provides significantly greater precision and resolution for a given radiation dose compared to traditional CT This is particularly valuable in imaging diagnostics that rely on detailed morphology such as high-resolution CT of lungs In order to achieve its full potential with as little radiation dose and contrast volume as possible with preserved image resolution the design of protocols for the photon-counting CT needs to be optimized
Autopsy studies on CVC-related thrombosis and vascular changes are few In a case series from 1994 changes in the vessel wall were examined macroscopically and biofilms were assessed with electron microscopy The presence of fibrin stocking on the surface of all CVCs n 72 and wall-mounted thrombosis was reported in 38 of cases In another autopsy study Forauer et al demonstrated severe CVC-related vascular changes that included intima damage with infiltration of media by inflammatory cells and varying degrees of adherent thrombus Wichmann et al published data showing a 38 prevalence of macroscopic catheter-related thrombosis in 61 human autopsies In a recently published autopsy study we showed that 12 out of 12 cases had CVC-related mural thrombosis at autopsy with most being located in the distal part of the CVC Rockholt et al
There are also a number of clinical studies that have investigated how common CVC-related thrombosis is using ultrasound In a well-designed prospective study 169 of ICU patients had subclinical CVK-related thrombosis The problem with the ultrasound method is that the distal part of the CVC is difficult to visualize with ultrasound which means that the thrombosis incidence risks being underestimated
Material and method In an attempt to investigate how common subclinical CVK-related thrombosis the current studies include photon-counting CT were designed
In substudy 1 photon counting CT is used to examine deceased intensive care patients referred for autopsy on clinical indication with CVC in-situ The CT will be focused on the vein with the CVC but a full body examination will also be done Both examination results will be compared with the clinical autopsy conducted after the examinations This first part of PHOTO CAT includes Scientific questions 1-3
In sub-study 2 living patients with CVC who are referred for CT scan without contrast will be eligable for inclusion After consent the study will be carried out with photon counting CT in two phases First the examination for which the patient was referred will be performed In the second phase a targeted examination is performed for research purposes of the vein with the CVC Within 12 hours before or after the CT scan it is planned to perform an ultrasound scan of the vein where the CVC is located The aim is to evaluate the performance of ultrasound examination in detecting CVC-related thrombosis compared to photon-counting CT Sub-study 2 of PHOTO CAT includes Questions 4-6
Analysis of data and statistics No one has previously reported photon-counting CT to detect CVC-related thromboses Therefore the current exploratory study is planned The results may form the basis for sample size calculation in future studies
Significance In patients with CVC subclinical CVC-related thromboses are very common These seem to cause surprisingly few clinical problems However it should be noted that several of the actual symptoms that CVC-related thrombosis can cause may go unnoticed or misinterpreted as symptoms of the disease that caused the patients to need of a CVC It is important to know the true incidence of subclinical CVC-related thrombosis in order to evaluate the risk-benefit of central venous access compared to alternatives peripheral venous access midline PICCLINE porth-a-cath and in the development of new less thrombogenic CVC materials
Scientific questions
1 Can the photon-counting CT diagnose subclinical CVK-related thromboses detected at later autopsy
2 How common are CVC-related thromboses in autopsies of deceased people with existing CVC
3 How does the performance of the photon counting DT compare to clinical autopsy
4 How common are CVC-related thromboses in a cohort that does photon-counting DT for various reasons and has a CVC
5 Can imaging be improved by adjustments to the DT protocol
6 Can an ultrasound scan on living patients diagnose subclinical CVK-related thrombosis detected by photon-counting CT
Background CVCs are essential in modern healthcare and have a wide range of applications They enable direct access to the central bloodstream and are used among other things to administer medicines nutrition and to monitor blood circulation Unfortunately they are associated with a variety of complications including thrombosis Studies report thrombosis incidences between 5 - 30 in living patients When the CVC is introduced into the blood vessel a number of physiological defense systems are initiated Inflammation and clotting are activated leading to the formation of a fibrin stocking around the catheter This can then develop into a catheter-related thrombosis which in turn can have serious consequences for the patient such as pulmonary embolism or infection
Photon-counting DT is the new generation of DT What distinguishes this from the traditional one is that the radiation through the body is detected with a new type of detector that measures each X-ray which provides significantly greater precision and resolution for a given radiation dose compared to traditional CT This is particularly valuable in imaging diagnostics that rely on detailed morphology such as high-resolution CT of lungs In order to achieve its full potential with as little radiation dose and contrast volume as possible with preserved image resolution the design of protocols for the photon-counting CT needs to be optimized
Autopsy studies on CVC-related thrombosis and vascular changes are few In a case series from 1994 changes in the vessel wall were examined macroscopically and biofilms were assessed with electron microscopy The presence of fibrin stocking on the surface of all CVCs n 72 and wall-mounted thrombosis was reported in 38 of cases In another autopsy study Forauer et al demonstrated severe CVC-related vascular changes that included intima damage with infiltration of media by inflammatory cells and varying degrees of adherent thrombus Wichmann et al published data showing a 38 prevalence of macroscopic catheter-related thrombosis in 61 human autopsies In a recently published autopsy study we showed that 12 out of 12 cases had CVC-related mural thrombosis at autopsy with most being located in the distal part of the CVC Rockholt et al
There are also a number of clinical studies that have investigated how common CVC-related thrombosis is using ultrasound In a well-designed prospective study 169 of ICU patients had subclinical CVK-related thrombosis The problem with the ultrasound method is that the distal part of the CVC is difficult to visualize with ultrasound which means that the thrombosis incidence risks being underestimated
Material and method In an attempt to investigate how common subclinical CVK-related thrombosis the current studies include photon-counting CT were designed
In substudy 1 photon counting CT is used to examine deceased intensive care patients referred for autopsy on clinical indication with CVC in-situ The CT will be focused on the vein with the CVC but a full body examination will also be done Both examination results will be compared with the clinical autopsy conducted after the examinations This first part of PHOTO CAT includes Scientific questions 1-3
In sub-study 2 living patients with CVC who are referred for CT scan without contrast will be eligable for inclusion After consent the study will be carried out with photon counting CT in two phases First the examination for which the patient was referred will be performed In the second phase a targeted examination is performed for research purposes of the vein with the CVC Within 12 hours before or after the CT scan it is planned to perform an ultrasound scan of the vein where the CVC is located The aim is to evaluate the performance of ultrasound examination in detecting CVC-related thrombosis compared to photon-counting CT Sub-study 2 of PHOTO CAT includes Questions 4-6
Analysis of data and statistics No one has previously reported photon-counting CT to detect CVC-related thromboses Therefore the current exploratory study is planned The results may form the basis for sample size calculation in future studies
Significance In patients with CVC subclinical CVC-related thromboses are very common These seem to cause surprisingly few clinical problems However it should be noted that several of the actual symptoms that CVC-related thrombosis can cause may go unnoticed or misinterpreted as symptoms of the disease that caused the patients to need of a CVC It is important to know the true incidence of subclinical CVC-related thrombosis in order to evaluate the risk-benefit of central venous access compared to alternatives peripheral venous access midline PICCLINE porth-a-cath and in the development of new less thrombogenic CVC materials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None